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Study to Compare Adjuvant Imm...

Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence

Last Updated: 2023-04-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

765 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-27

Study Completion Date

2022-09-22

Brief Summary

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The main purpose of this study is to compare the efficacy of bempegaldesleukin plus nivolumab versus nivolumab in patients with completely resected Stage IIIA/B/C/D, or Stage IV cutaneous melanoma who are at high risk for recurrence.

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Detailed Description

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The main purpose of this study is to compare the efficacy, as measured by recurrence-free survival (RFS) by blinded independent central review (BICR), of bempegaldesleukin plus nivolumab versus nivolumab in patients with completely resected Stage IIIA (lymph node \[LN\] metastasis \> 1 mm), Stage IIIB/C/D, or Stage IV (American Joint Committee on Cancer \[AJCC\] 8th edition) cutaneous melanoma with no evidence of disease (NED) who are at high risk for recurrence.

Conditions

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Melanoma Melanoma Stage III Melanoma Stage IV Melanoma (Skin)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be randomized in a 1:1 ratio to one of two treatment arms

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Combination of bempegaldesleukin (NKTR-214) + nivolumab

Arm A: Participants will receive bempegaldesleukin (NKTR-214) IV in combination with nivolumab every 3 weeks.

Group Type EXPERIMENTAL